KUALA LUMPUR, Dec 29 — LEO Pharma A/S, a global leader in medical dermatology, announced the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Atopic dermatitis is a chronic, inflammatory, skin disease characterised by intense itch and eczematous lesions. Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.
According to a statement, Adbry can be used with or without topical corticosteroids. It is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.
“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find a suitable treatment option for this chronic and debilitating disease,” said Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S, Anders Kronborg.
“As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”
The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.
Safety data was evaluated from a pool of five randomised, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.
Adbry will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600mg followed by 300mg every other week.
Adbry can be used with or without TCS. A dosage of 300mg every four weeks may be considered for patients below 100kg who achieve clear or almost clear skin after 16 weeks of treatment.
Source: BERNAMA News Agency